MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number	ATELLICA IM 1300 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) regarding an erroneously elevated high-sensitivity troponin i (tnih) result obtained on a patient sample on an atellica im 1300 analyzer.Quality control (qc) was in range on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit the cse, inspected the analyzer, adjusted the vacuum pressure, performed auto-check, which passed.Then, the cse performed total service visit (tsv) and verified the wash station operation, ran qc and patient results which recovered acceptably.Siemens evaluated the event and ruled out reagent issue was ruled out as qc was in range and other samples were not affected.Siemens reviewed the instrument data and determined that that there was no issue with the delivery of tnih reagents and delivery of samples.Siemens further evaluated the event and determined that the issues with the wash station can potentially cause an increase in relative light units (rlus) and therefore elevated results could be generated.The instrument is performing according to the specification.No further evaluation is required.
Event or Problem Description
The customer reported that they obtained an erroneously elevated high-sensitivity troponin i (tnih) result on a patient sample on an atellica im 1300 analyzer.The erroneously elevated result was reported to the physician(s) and was questioned.A new sample was drawn from the same patient and processed twice on the original analyzer and once on an alternate atellica im 1300 analyzer.The reprocessed results matched the patient¿s clinical picture and considered correct.The result of 3.223 ng/l from an alternate atellica im 1300 analyzer was reported as the correct result to the physician(s).There is no known reports of patient intervention or adverse health consequences due to the erroneously elevated tnih result.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Common Device Name: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22042573
• Report Number: 2432235-2025-00134
• Device Sequence Number: 12957125
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown